View Grant Opportunity
Single-Site Investigator-Initiated Clinical Trials (R61/R33 Clinical Trial Required)
National Institutes of Health
PAR-25-028
HHS-NIH11
General Information
Est. Program Funding:
Closing Date:
Expected No. of Awards
Award Ceiling
Opportunity Number:
PAR-25-028
Owning Agency:
HHS-NIH11
Opportunity Category:
Discretionary (D)
Synopsis
This Notice of Funding Opportunity (NOFO) supports applications to develop and implement investigator-initiated single site clinical trials including efficacy, comparative effectiveness, pragmatic and/or implementation research clinical trials. These trials may include ones that test different therapeutic, behavioral, and/or prevention strategies. Trials for which this NOFO applies must be relevant to the research mission of the NHLBI and meet the NIH definition of a clinical trial (see NOT-OD-15-015). For additional information about the mission, strategic vision, and research priorities of the NHLBI, applicants are encouraged to consult the NHLBI website.This NOFO will utilize a bi-phasic, milestone-driven mechanism of award. The objective of the application is to present the scientific rationale for the clinical trial and a comprehensive scientific and operational plan that describes it. The application should address project management, subject recruitment and retention, performance milestones, scientific conduct of the trial, and dissemination of results. The multiple PD/PI model is strongly encouraged but not required. Applicants are encouraged to include a PD/PI with expertise in biostatistics, clinical trial design, and coordination. |
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| Response Date | Jan 11, 2026 12:00:00 AM EST |
| Posting Date | Dec 11, 2024 12:00:00 AM EST |
| Archive Date | Feb 10, 2026 12:00:00 AM EST |
| Award Ceiling | N/a |
| Award Floor | N/a |
| Cost Sharing | No |
Eligibility
| Eligible Applicants | Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education, Special district governments, Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education, Public and State controlled institutions of higher education, For profit organizations other than small businesses, State governments, Native American tribal governments (Federally recognized), Small businesses, Others (see text field entitled "Additional Information on Eligibility" for clarification), County governments, Public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal governments), City or township governments, Independent school districts, Private institutions of higher education |
| Additional Info on Eligibility: | Other Eligible Applicants include the following: Alaska Native and Native Hawaiian Serving Institutions; Asian American Native American Pacific Islander Serving Institutions (AANAPISISs); Eligible Agencies of the Federal Government; Faith-based or Community-based Organizations; Hispanic-serving Institutions; Historically Black Colleges and Universities (HBCUs); Indian/Native American Tribal Governments (Other than Federally Recognized); Non-domestic (non-U.S.) Entities (Foreign Organizations); Regional Organizations; Tribally Controlled Colleges and Universities (TCCUs) ; U.S. Territory or Possession. |
Additional Information
| Agency Name | National Institutes of Health |
| Link to Additional Information: | https://grants.nih.gov/grants/guide/pa-files/PAR-25-028.html |
| Grantor Contact Information: |
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CFDA Program(s)
- 93.233: National Center on Sleep Disorders Research
- 93.837: Cardiovascular Diseases Research
- 93.838: Lung Diseases Research
- 93.839: Blood Diseases and Resources Research
- 93.840: Translation and Implementation Science Research for Heart, Lung, Blood Diseases, and Sleep Disorders
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